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Trials / Completed

CompletedNCT02470390

Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl

An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Depomed · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

Detailed description

An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Conditions

Interventions

TypeNameDescription
DRUGFentanylLazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Timeline

Start date
2014-11-01
Primary completion
2015-01-01
Completion
2015-04-01
First posted
2015-06-12
Last updated
2018-03-16
Results posted
2018-03-16

Source: ClinicalTrials.gov record NCT02470390. Inclusion in this directory is not an endorsement.

Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl (NCT02470390) · Clinical Trials Directory